Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Study on Dynamic Multimodal Analgesia Regimen Integrated With Traditional Chinese and Western Medicine After Perianal Abscess Surgery

2 de agosto de 2026 actualizado por: The Affiliated Hospital of Putian University

Study on Dynamic Multimodal Analgesia Regimen Integrated With Traditional Chinese and Western Medicine After Perianal Abscess Surgery: A Single-Center, Prospective, Open-Label Randomized Clinical Trial

Background:Perianal abscess is a common acute anorectal pyogenic disease (8%-25% of anorectal illnesses), mainly seen in men aged 20-40. Over 90% suffer severe postoperative pain, impairing healing, triggering anxiety or sepsis and raising medical loads. Western multimodal analgesia eases pain yet causes dependence and side effects. TCM sitz baths clear heat, reduce swelling and promote recovery. Few personalized combined protocols are available, and integrated Chinese-Western synergies are insufficiently exploited. This optimized integrated intervention guides postoperative pain nursing.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

147

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Fujian
      • Putian, Fujian, Porcelana, 351100
        • The Affiliated Hospital of Putian University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Aged between 18 and 75 years old (18 ≤ age ≤ 75);
  2. Diagnosed with primary perianal abscess via digital rectal examination, anorectal ultrasound or MRI, and scheduled for incision and drainage or radical surgery;
  3. The maximum diameter of the abscess cavity ≥ 2 cm, or with obvious abscess cavity formation;
  4. Patients are willing and capable of participating in the pain management protocol, fully understand the significance of pain management, and can actively cooperate with study procedures;
  5. No severe coagulation disorders.

Exclusion Criteria:

  1. Complicated with specific infectious diseases such as Crohn's disease and tuberculosis;
  2. Unclear source of postoperative pain, i.e., the origin of pain cannot be confirmed or the pain is unrelated to surgery;
  3. Presence of definite contraindications, including drug allergy or inability to tolerate any pain management measures adopted in this trial;
  4. Pregnant or lactating women;
  5. Patients unable to cooperate with the study, such as those with cognitive impairment, history of mental illness, communication barriers and other conditions;
  6. Patients with long-term analgesic medication use and established drug tolerance;
  7. Complicated with uncontrolled cardiovascular and cerebrovascular diseases (NYHA cardiac function class Ⅲ-Ⅳ), hepatic and renal insufficiency (Child-Pugh class C or eGFR < 30 mL/min/1.73 m²), etc.;
  8. Abscess secondary to rectal neoplasms, trauma or iatrogenic injury;
  9. Severe postoperative complications (such as massive hemorrhage, sepsis) or concurrent infections at other sites;
  10. Patients receiving only non-surgical treatments such as simple needle aspiration of pus.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Western Multimodal Analgesia Group
Western multimodal analgesia. Dynamic whole-course NRS evaluation was performed: baseline measurement preoperatively, regular rest/activity pain checks and breakthrough pain assessment postoperatively, plus follow-up reassessment after discharge. Stepwise stratified medication was applied alongside non-pharmacological measures including potassium permanganate sitz bath, health education and psychological counseling. A pain management team adjusted regimens individually via daily ward rounds.
TCM sitz bath
Experimental: Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group
integrated Chinese-Western multimodal analgesia. All interventions of Group B were adopted, with additional TCM sitz bath and TCM nursing; assessment and Western medicine protocols remained identical to Western Multimodal Analgesia Group
TCM sitz bath

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Numerical Rating Scale,NRS
Periodo de tiempo: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
The Numerical Rating Scale (NRS) for pain assessment ranges from 0 to 10, with higher scores indicating more severe pain and poorer outcomes.
Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
total postoperative analgesic consumption
Periodo de tiempo: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
Total consumption of analgesics was converted to morphine equivalent daily dose (MEDD) for intergroup comparison.
Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
postoperative quality of life indicators
Periodo de tiempo: at day 3 and month 1 postoperatively
The Short-Form 36 (SF-36) Health Survey was employed to evaluate quality of life, with each domain scored from 0 (minimum) to 100 (maximum), and higher scores reflecting more favorable health status and better quality of life.
at day 3 and month 1 postoperatively

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
postoperative urinary retention
Periodo de tiempo: 24 hours postoperatively
Patients were placed in the supine position with a moderately full bladder. The ultrasound probe was positioned above the pubic symphysis, and the anteroposterior, transverse, and longitudinal diameters of the bladder were measured. The post-void residual urine volume was calculated using the formula: bladder volume (mL) ≈ 0.52 × length × width × height (cm). A residual volume of <50 mL was considered normal, 50-200 mL indicated mild urinary retention or impaired voiding, and >200 mL was diagnostic of postoperative urinary retention. Complete inability to void with a bladder volume of >400 mL was defined as acute urinary retention.
24 hours postoperatively
secondary hemorrhage
Periodo de tiempo: 24 hours postoperatively
Active oozing from the surgical wound occurring beyond 24 hours postoperatively, with a blood loss of ≥5 mL, requiring dressing change and continuous compression hemostasis with sterile gauze; secondary suturing is indicated if bleeding cannot be controlled.
24 hours postoperatively
perianal edema
Periodo de tiempo: within 72 hours postoperatively
Perianal edema was defined as visible significant soft-tissue swelling around the operative site, accompanied by local tenderness, with the edema persisting for more than 72 hours.
within 72 hours postoperatively
assessment of sexual function
Periodo de tiempo: assessed preoperatively and at 1 month postoperatively
Erectile function in male patients was evaluated using the International Index of Erectile Function-5 (IIEF-5), which has a total score ranging from 5 (minimum) to 25 (maximum), with higher scores denoting better erectile function. For female patients, sexual function was assessed using the Female Sexual Function Index (FSFI), with total scores ranging from 2 to 36, where a higher score indicates better sexual function.
assessed preoperatively and at 1 month postoperatively

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de julio de 2026

Finalización primaria (Estimado)

30 de julio de 2026

Finalización del estudio (Estimado)

30 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de agosto de 2026

Publicado por primera vez (Actual)

4 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PutianU-0013

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir